Cleared Traditional

K955893 - EVERYTIME TRANSFUCER COVER

K955893 is an FDA 510(k) clearance for EVERYTIME TRANSFUCER COVER, manufactured by Amedic AB. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 746-day FDA review.

K955893 · Amedic AB · Radiology device
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Dec 1997
Decision
746d
Days
Class 2
Risk

K955893 is an FDA 510(k) clearance for the EVERYTIME TRANSFUCER COVER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Amedic AB (Sollentuna, SE). The FDA issued a Cleared decision on December 30, 1997 after a review of 746 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Amedic AB devices

FDA 510(k) Submission Details - K955893

510(k) Number K955893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date December 30, 1997
Days to Decision 746 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
639d slower than avg
Panel avg: 107d · This submission: 746d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 324
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